Pharmexa moves to phase 3 of cancer vaccine trials

By Lisa Kerner

Erie, Pa., Jan. 5 - Pharmexa A/S continues to move forward with clinical trials on its GV1001 cancer vaccine and is preparing two phase 3 studies of the treatment in pancreatic cancer.

These two trials, the PrimoVax and the TeloVax trial, will enroll patients with inoperable pancreatic cancer - approximately 90% of all pancreatic cancer patients - and collectively include more than 1,600 people.

To date, GV1001, a peptide vaccine that activates the immune system to recognize and kill cancer cells, has been tested in seven small clinical studies for non-small cell lung cancer, malignant melanoma and pancreatic cancer. More than 120 patients have been vaccinated with GV1001, with significant signs of clinical effect and no major side effects. Because it targets the telomerase enzyme, GV1001 could be developed into a universal cancer vaccine, according to a news release.

Next month, Pharmexa will file a Clinical Trial Application to start the PrimoVax phase 3 trial. Preparations for this trial are ahead of schedule, according to the company. The trial will include 520 patients in approximately 10 countries. Results are expected in 2009.

Pharmexa's TeloVax phase 3 trial is expected to expand to 1,100 patients, up from 750 patients. This trial was initially planned for the end of 2005. However, the trial planner, the National Cancer Research Pancreatic Cancer Subgroup in the United Kingdom, is expected to change the study protocol to include other chemotherapeutic drugs. This will delay the start until early 2006 while expanding the number of trial participants. The protocol change is expected to strengthen the clinical data for GV1001.

The Pancreatic Cancer Subgroup expects results in 2010. The trial will be sponsored by the National Cancer Research Institute and will take place in up to 80 cancer centers in the United Kingdom.

Also this year, Pharmexa will apply for Orphan Drug Status in the United States and Europe for the use of GV1001 in the treatment of pancreatic cancer. Orphan designation promotes the development of drugs that are expected to treat or prevent infrequent diseases where there is a great need for new treatments. Advantages of achieving Orphan Drug Status are market exclusivity, scientific advisory, fee reductions and a faster approval process.

Pharmexa is planning a new phase 2 trial with GV1001 in hepatocellular carcinoma, or liver cancer. A Clinical Trial Application for this study will be filed by the second quarter. The third-most lethal type of cancer, hepatocellular carcinoma reportedly causes approximately 600,000 deaths annually and is related to factors such as hepatitis B and C, and cirrhosis of the liver. Up to 45 patients will be enrolled in the study, which will be conducted at a number of centers in Europe. Phase 2 data is expected to be available at the end of 2007.

Pharmexa, based in Horsholm, Denmark, is a leader in the field of active immunotherapy and vaccines for the treatment of serious chronic and infectious diseases.

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